Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study
- Conditions
- Breast Cancer
- Registration Number
- NCT02393924
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 311
- Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
- Able and willing to provide written informed consent and to comply with the study protocol
- There are no exclusion criteria for entry into this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Receiving Each Unique Treatment Regimen Overall Baseline up to approximately 8 years Percentage of Participants Receiving Each Unique Treatment Regimen Sequence Baseline up to approximately 8 years Progression-Free Survival From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years) Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy Baseline up to approximately 8 years
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
Percentage of Participants by Reasons for Treatment Modification Baseline up to approximately 8 years Time to Treatment Failure From the date of initiation of treatment to the date of treatment stopped or switched or death from any cause (up to approximately 8 years) Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Baseline up to approximately 8 years Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score Baseline up to approximately 8 years (assessed every 3 months) Work Productivity and Activity Impairment (WPAI) Questionnaire Score Baseline up to approximately 8 years (assessed every 3 months) Percentage of Participants with CNS-only Disease Progression From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens Baseline up to approximately 8 years Overall Survival (OS) From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years) Duration of Response (DoR) From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years) Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score Baseline up to approximately 8 years (assessed every 3 months) Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country Baseline up to approximately 8 years Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens Baseline up to approximately 8 years Percentage of Participants With Central Nervous System (CNS) as First Site of Progression From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics Baseline up to approximately 8 years Number of Treatment Regimens Received Baseline up to approximately 8 years
Trial Locations
- Locations (29)
Kent & Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Chesterfield Royal Hospital
🇬🇧Chesterfield, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
🇬🇧Cornwall, United Kingdom
Castle Hill Hospital; The Queens Centre for Oncology and Haematology
🇬🇧Cottingham, United Kingdom
Hairmyres Hospital; Oncology Dept
🇬🇧East Kilbride, United Kingdom
Queen Elizabeth Hospital
🇬🇧London, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom
Forth Valley Royal Hospital ; Oncology Department
🇬🇧Larbert, United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
🇬🇧London, United Kingdom
Charing Cross Hospital; Medical Oncology.
🇬🇧London, United Kingdom
Scroll for more (19 remaining)Kent & Canterbury Hospital🇬🇧Canterbury, United Kingdom